Manager / Director Clinical Data Management & Biostatistics Location: Northern Indiana Industry: Biotechnology This is a high profile role and ground floor opportunity with a progressive and growing biotechnology company performing oncology research. The Company was founded in 1995 and is well funded with a robust pipeline of drug candidates. The incumbent will serve as a key member of the company’s research team and will supervise a team of data management professionals and functional activities, and processes to ensure all clinical goals and objectives are met. Our client is seeking a degreed individual with seven or more year’s industry experience in a data management role including supervisory experience in clinical data management supporting oncology clinical trials. Candidates must also be familiar with SAS programming and possess data analysis experience. Position Description: The primary focus of this position is to oversee, guide, manage and support clinical trials methodology and data, planning and performing statistical analysis of clinical trials. The position will work on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. This position will participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people. Responsibilities: · Establish and coordinate goals for department · Coordinate and prioritize across trials and within the department · Ensure ongoing employee training to enhance the skills and expand the knowledge of direct reports · Oversee the outsourcing of Data Management and Biostatistics to CROs · Develop positive partnerships with CROs and ensure a high standard of deliverables is maintained · Establish and examine procedural infrastructure including existing working processes and methods, · Development of new processes and methods as needed · Plan and perform statistical analysis for clinical trials · Provide statistical, clinical trial methodology, and regulatory input (e.g., trial design, sample size estimation, randomization, statistical methods, and query checks for clinical trial data) · Contribute to CRFs and edit specifications · Review protocols and clinical study reports for consistency and accuracy · Produce detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety · Responsible for the management and analysis of clinical trial data, provide statistical input into the reporting of clinical trial results, and clearly communicate statistical results and concepts to non-statisticians · Participate in interactions with regulatory agencies as required · Responsible for in-house SOPs to support Data Management and Biostatistical activities. Requirements: · A BS/RN or BS degree in Statistics/Biostatistics or related life sciences discipline with at least 7 or more years of related experience in pharmaceutical/biotech setting. · Previous Management and project experience is required. · Broad experience in clinical statistics, data management, and SAS programming are required. · Previous experience in preparing a NDA, CTD, or eCTD. · Excellent team skills and written and oral communication skills. · Strong ability to handle multiple projects simultaneously. · Capable of representing the Company in statistical discussions with the FDA and other major regulatory authorities worldwide. · Oncology experience is required.